{"id":33476,"date":"2022-05-21T15:25:29","date_gmt":"2022-05-21T13:25:29","guid":{"rendered":"https:\/\/www.ivo.es\/research\/ceim\/"},"modified":"2026-02-06T13:03:28","modified_gmt":"2026-02-06T12:03:28","slug":"ceim","status":"publish","type":"page","link":"https:\/\/www.ivo.es\/en\/research\/ceim\/","title":{"rendered":"CEIm"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"33476\" class=\"elementor elementor-33476 elementor-28211\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-2618380 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2618380\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3b293935\" data-id=\"3b293935\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6e1de856 elementor-widget elementor-widget-heading\" data-id=\"6e1de856\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Drug Research Ethics Committee (in Spanish, Comit\u00e9 de \u00c9tica de la Investigaci\u00f3n con medicamentos, CEIm) <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-inner-section elementor-element elementor-element-241432e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"241432e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-76ef598\" data-id=\"76ef598\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6aa0775b elementor-widget elementor-widget-text-editor\" data-id=\"6aa0775b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>It is the independent body, made up of healthcare professionals and non-healthcare members, responsible for ensuring the protection of the rights, safety and well-being of subjects participating in a <a href=\"https:\/\/ivo22.gyoza.tech\/investigacion\/ensayos-clinicos\/\">clinical trial<\/a> and for providing public assurance in this regard.<\/p><p> Its purpose is to supervise and monitor clinical trials on an ongoing basis in order to ensure that they comply with current regulations on methodological and ethical aspects.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-7a7f174\" data-id=\"7a7f174\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-74760465 elementor-widget elementor-widget-image\" data-id=\"74760465\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"640\" height=\"408\" src=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2025\/01\/IVO-QUIMIO-01-1024x653.jpg\" class=\"attachment-large size-large wp-image-40211\" alt=\"\" srcset=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2025\/01\/IVO-QUIMIO-01-1024x653.jpg 1024w, https:\/\/www.ivo.es\/wp-content\/uploads\/2025\/01\/IVO-QUIMIO-01-300x191.jpg 300w, https:\/\/www.ivo.es\/wp-content\/uploads\/2025\/01\/IVO-QUIMIO-01-768x490.jpg 768w, https:\/\/www.ivo.es\/wp-content\/uploads\/2025\/01\/IVO-QUIMIO-01.jpg 1200w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-92c771f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"92c771f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e1a771e\" data-id=\"e1a771e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fc3ae6d elementor-widget elementor-widget-heading\" data-id=\"fc3ae6d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FIVO CEIm<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0d0530f elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"0d0530f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-0d0530f\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"0d0530f\" data-accordion-type=\"accordion\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"members-of-the-ceim\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-1361\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">Members of the CEIm<\/span><\/div><div id=\"elementor-tab-content-1361\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"members-of-the-ceim\"><p><b>President<\/b>:<\/p><p>Esteban Morcillo S\u00e1nchez (Clinical Pharmacologist).<\/p><p><b>Vice-President:<\/b><\/p><p>\u00a0<\/p><p><b>Technical Secretary:<\/b><\/p><p>Carlos Andr\u00e9s Blasco (Pharmacist Specialising in Hospital Pharmacy).<\/p><p><b>Board Members:<\/b><\/p><ul><li>Ismael Pastor Climente (Pharmacist Specialising in Hospital Pharmacy).<\/li><li>Joaqu\u00edn Gavil\u00e1 Gregori (Doctor Specialising in Oncology).<\/li><li>\u00c1ngel Luis Guerrero Zotano (Doctor Specialising in Oncology).<\/li><li>Lourdes Bello Luna (Graduate in Law).<\/li><li>M\u00aa Jos\u00e9 Ortega Garc\u00eda (Graduate in Law).<\/li><li>Julio Tudela Cuenca (Pharmacist Specialising in Clinical Analyses).<\/li><li>Jose Luis Trillo (Primary Care Pharmacist).<\/li><li>Luis G\u00f3mez de Membrillera Quesada (Specialist in Family and Community Medicine).<\/li><li>David Herv\u00e1s Mar\u00edn (Graduate in Biostatistics).<\/li><li>Josefina Balaguer Cusi (Non-professional Member).<\/li><li>Esteban Mesas Plaza\u00a0(Graduate in Nursing).<\/li><li>Elena Oliete Ram\u00edrez (Doctor Specialising in Family and Community Medicine).<\/li><li>Antonio Jos\u00e9 Revert Ventura (Doctor Specialising in Radiology).<\/li><li>Miguel \u00c1ngel Sanz Alonso (Haematology Specialist).<\/li><\/ul><p><strong>CEIm Technical Secretary Coordinator:<\/strong><\/p><p>Bernat Navarro Aguir (Graduate in Pharmacy)<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"clinical-trial-requirements\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-1362\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">Clinical trial requirements<\/span><\/div><div id=\"elementor-tab-content-1362\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"clinical-trial-requirements\"><p>The documentation to be submitted for the evaluation of clinical trials with medicinal products\/medical devices is as indicated in the &#8220;<a href=\"https:\/\/www.aemps.gob.es\/investigacionClinica\/medicamentos\/docs\/Instrucciones-realizacion-ensayos-clinicos.pdf\" target=\"_blank\" rel=\"noopener\">Document of instructions of the Spanish Agency of Medicine and Medical Devices for conducting clinical trials in Spain (in Spanish)<\/a>&#8221; and in the &#8220;<a href=\"https:\/\/www.aemps.gob.es\/investigacionClinica\/medicamentos\/docs\/memorando-colaboracion-AEMPS-comites-investigacion-medicamentos. pdf\" target=\"_blank\" rel=\"noopener\">Memorandum of Collaboration and Exchange of Information between the Spanish Agency of Medicine and Medical Devices and the Ethics Committees for Research on medicinal products (a translation from Spanish)<\/a>&#8220;.<\/p><p><strong>Part I documents to be sent to the AEMPS (Spanish Agency for Medicine and Medical Devices) and the CEIm *<\/strong><\/p><p>\u00a0<\/p><ul><li>Submission letter<\/li><li>Application form<\/li><li>Authorisation from the sponsor to the applicant, if applicable<\/li><li>Protocol summary<\/li><li>Protocol<\/li><li>Researcher&#8217;s manual or data sheet for an investigational medicinal product<\/li><li>Data sheet or researcher&#8217;s manual for non-investigational (auxiliary) medicinal products<\/li><li>Scientific Advice and Paediatric Investigational Plan<\/li><\/ul><p>.<\/p><p><strong> Part II documents to be sent only to CEIm*.<\/strong><\/p><ul><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/PRODECIMIENTOS-Y-MATERIAL-UTILIZADOS-PARA-EL-RECLUTAMIENTO.docx\" target=\"_blank\" rel=\"noopener\"> Documents related to the procedures and material used for recruiting subjects. <\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/MODELO-CEIm-FIVO-DE-HIP-CI-ENSAYOS.docx\" target=\"_blank\" rel=\"noopener\"> Information sheets and informed consent documents <\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/IDONEIDAD-DEL-INVESTIGADOR.docx\" target=\"_blank\" rel=\"noopener\"> Suitability of the researcher <\/a><\/li><\/ul><p><strong> Documentation to be provided by each centre:<\/strong><\/p><ul><li>Principal Investigator\u2019s Curriculum Vitae<\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/IDONEIDAD-DE-LAS-INSTALACIONES-GENERICO.docx\" target=\"_blank\" rel=\"noopener\"> Adequacy of facilities <\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/MODELO-DECLARACION-CONFLICTO-DE-INTERESES-IP.docx\" target=\"_blank\" rel=\"noopener\"> Conflict of interest of the Principal Investigator <\/a><\/li><li>Principal Investigator&#8217;s Certificate of Good Clinical Practices<\/li><li>Proof of insurance coverage or financial guarantee<\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/MEMORIA-ECONOMICA-GENERAL-1.odt\" target=\"_blank\" rel=\"noopener\"> Economic Report<\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/Tarifas-Facturacion_Exencion-Evaluacion-CEIm-FIVO-todos.doc\"> CEIm fee invoicing data form.<\/a> The invoice is issued after completing the evaluation process. The complete document must be submitted together with the application. If an exemption is requested, see the conditions in the document.<\/li><\/ul><p>For clinical trials with medicinal products, the sponsor must submit the documentation through the Clinical Trials Portal of the Ministry of Health, Social Policy and Equality.<\/p><p>For clinical trials with medical devices, the sponsor must submit the scanned documentation by e-mail to ceim@fivo.org. In this e-mail, the sponsor must indicate the title of the study, the protocol code, the sponsor, and the Principal Investigator of FIVO (if applicable).<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pre-requisites-for-the-initiation-of-observational-studies-with-drugs-in-spanish-estudio-observacional-con-medicamento-eom\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"3\" aria-controls=\"elementor-tab-content-1363\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">Pre-requisites for the initiation of Observational Studies with Drugs (in Spanish, Estudio Observacional con medicamento, EOm)<\/span><\/div><div id=\"elementor-tab-content-1363\" class=\"eael-accordion-content clearfix\" data-tab=\"3\" aria-labelledby=\"pre-requisites-for-the-initiation-of-observational-studies-with-drugs-in-spanish-estudio-observacional-con-medicamento-eom\"><p>The sponsor must submit all scanned documentation (PDF) by e-mail to<u><a href=\"mailto:ceim@fivo.org\"> ceim@fivo.org<\/a><\/u>.<\/p><p><strong> LOCAL DOCUMENTATION <\/strong> (<a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/1-REQUISITOS-ESTUDIO-OBSERVACIONAL-CON-MEDICAMENTO-EOm.pdf\"> DOWNLOAD EOm REQUIREMENTS <\/a>):<\/p><p>For EOm (Observational Studies with Drugs) that, at the time of submission, do not have a favourable opinion as issued by the Drug Research Ethics Committee (CEIm), the following documentation must be submitted <u>in PDF format<\/u> for review by the CEIm-FIVO:<\/p><p>The sponsor must submit all scanned documentation by e-mail to <a href=\"mailto:ceim@fivo.org\">ceim@fivo.org<\/a><\/p><p><strong> GENERAL DOCUMENTATION: (Only required in PDF format)<\/strong><\/p><ol><li><strong><u> Cover letter (signed)<\/u><\/strong><strong>.<\/strong> The letter must specify the sponsor, the title of the study, the code, the rincipal investigator at the centre and the list of the documentation attached to the application.<\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/2-FORMULARIO-DE-REGISTRO-ESTUDIO-INTERNO-y-o-AMBITO-UNIVERSITARIO-todos.docx\" target=\"_blank\" rel=\"noopener\"><strong> Internal study and\/or university registration form (signed)<\/strong><\/a><strong>.<\/strong> To be completed only for internal and\/or university studies.<\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/3-INDICE-ORIENTATIVO-PROTOCOLO-alumnos.docx\" target=\"_blank\" rel=\"noopener\"><strong><u> Complete protocol<\/u><\/strong><\/a>, adapted as far as possible to the structure and content detailed in Annex I of the Spanish <em>&#8220;Royal Decree 957\/2020, of 3 November, regulating observational studies with drugs meant for human use&#8221;<\/em>. It may be accepted in English, with a summary in Spanish. Its version and date shall be indicated.<\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/4-MODELO-CEI-FIVO-DE-HIP-CI-EOm.docx\" target=\"_blank\" rel=\"noopener\"><strong> Information sheet for participating subjects and informed consent form<\/strong><\/a>, or justification for <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/4-MODELO-SOLI_EXENCION-HIP_CI.docx\" target=\"_blank\" rel=\"noopener\">exemption<\/a>. CEIm-FIVO form is available. Version and date to be noted.<\/li><li><strong><u> Case Report Form (CRF).<\/u><\/strong><\/li><li><strong><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/6-MEMORIA-ECONOMICA-GENERAL-EOm-todos.docx\" target=\"_blank\" rel=\"noopener\"> General economic report.<\/a> <\/strong> Financing sources for the study and compensation foreseen for the participating subjects and researchers, if applicable. In the case of non-commercial clinical research, the sponsor must submit a declaration signed by the sponsor and the coordinating researcher that the study complies with all the conditions referred to in paragraph e) of article 2.2 of Royal Decree 1090\/2015, of 4 December.<\/li><li><strong><u>List of researchers<\/u><\/strong> from each of the healthcare centres in which the study is proposed to be conducted and the number of participating subjects intended to be included in each autonomous community. If the study is planned to be carried out in other countries, a list of the countries must also be included.<\/li><li><strong><u> Responsibility delegation agreement (CRO).<\/u><\/strong> If the application is not submitted by the sponsor, a document indicating the tasks delegated by the sponsor to the person or company acting on his or her behalf must be included (if applicable).<\/li><\/ol><ol><li><strong><u> Evidence of approval of the protocol by the relevant body, <\/u><\/strong> in the case of a study imposed on the marketing authorisation holder of a medicinal product by the national competent authority or the European Commission (where applicable).<\/li><li><strong><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/10-Tarifas-Facturacion-o-Exencion-por-Evaluacion-CEIm-FIVO-todos.doc\" target=\"_blank\" rel=\"noopener\"> Invoice request \/ Application for evaluation fee waiver (signed)<\/a><u>.<\/u><\/strong><\/li><\/ol><p><strong> LOCAL DOCUMENTATION<\/strong> (<strong> To be sent to the CEIm Secretariat duly SIGNED<\/strong>, according to the CEIm-FIVO&#8217;s own form):<\/p><p><strong><u>NOTE:<\/u><\/strong><\/p><ul><li><strong> EOm promoted by an external Sponsor <\/strong>: The <strong>FINCIVO Coordinator<\/strong> (<a href=\"mailto:coordinacion@fincivo.org\">coordinacion@fincivo.org<\/a>) will be asked to manage this documentation and send it to the Sponsor.<\/li><li><strong> EOm promoted by FIVO&#8217;s PR<\/strong>: The Researcher will manage it <strong>him\/herself<\/strong>.<\/li><\/ul><ol><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/11-COMPROMISO-IP-Y-AUTORIZACION-JS-EOm-todos.doc\" target=\"_blank\" rel=\"noopener\"><strong> Commitment of the Researcher and authorisation of the Head of Service.<\/strong><\/a><\/li><li><strong><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/12-AUTORIZACION-JS-IMPLICADO-EOm-todos.doc\" target=\"_blank\" rel=\"noopener\"> Agreement of involved services.<\/a> <\/strong>Extraordinary tests and\/or collaboration with other services (only when applicable).<\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/13-FORMULARIO-CARACTERISTICAS-GENERALES-ESTUDIO-EOm-todos.docx\" target=\"_blank\" rel=\"noopener\"><strong> Form on general characteristics of the study.<\/strong><\/a><\/li><li><strong><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/14-CUESTIONARIO-CON-MEMORIA-ECONOMICA-EOm-0-todos.docx\" target=\"_blank\" rel=\"noopener\"> Questionnaire for studies with \u20ac0 economic report<\/a><u>.<\/u><\/strong> Only in the case of studies with \u20ac0 economic report.<\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/15-COMPROMISO-CONFIDENCIALIDAD-ESTUDIANTES-ACTUALIZADO-2019-alumnos.pdf\" target=\"_blank\" rel=\"noopener\"><strong> Confidentiality agreement for trainees<\/strong><\/a>. Only in the case of university studies.<\/li><li><strong><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/16-CLAUSULA-RGPD_estudiantesIVO-alumnos.pdf\" target=\"_blank\" rel=\"noopener\">GDPR clause<\/a><u>. <\/u><\/strong>Only in the case of studies at the university level.<\/li><\/ol><p>The observational study with drugs (EOm) cannot begin at the centre until the corresponding management approval has been obtained (if the sponsor is FIVO staff), or the corresponding contract has been signed (if the sponsor is external to the centre). To this end, it is a minimum requirement to provide proof of having received the authorisations for the funding requested. Both the management approval and the contract must be requested at the following e-mail address: <a href=\"mailto:contratosestudios@fivo.org\">contratosestudios@fivo.org<\/a><\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"requirements-for-research-projects\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"4\" aria-controls=\"elementor-tab-content-1364\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">Requirements for Research Projects<\/span><\/div><div id=\"elementor-tab-content-1364\" class=\"eael-accordion-content clearfix\" data-tab=\"4\" aria-labelledby=\"requirements-for-research-projects\"><p>The sponsor must submit all scanned documentation (PDF) by e-mail to <u><a href=\"mailto:ceim@fivo.org\">ceim@fivo.org<\/a><\/u>.<\/p><p><strong> DOCUMENTATION TO BE SUBMITTED <\/strong> (<a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/1-REQUISITOS-PROYECTOS-DE-INVESTIGACION-todos.pdf\" target=\"_blank\" rel=\"noopener\"> DOWNLOAD REQUIREMENTS FOR RESEARCH PROJECTS [PDF in Spanish]. <\/a>):<\/p><p>The following documentation must be submitted <u>IN PDF FORMAT<\/u> for review by the REC-FIVO:<\/p><p><strong>GENERAL DOCUMENTATION<\/strong><\/p><p>1. Cover letter (signed). The letter must specify the sponsor, the title of the study, the code, the principal investigator at the centre, and the list of the documentation attached to the application.<\/p><p>2. <a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2019\/04\/REQ-PI-FORMULARIO-DE-REGISTRO-ESTUDIO-INTERNO-Y-O-AMBITO-UNIVERSITARIO.docx\" target=\"blank\"><u> Internal study and\/or university registration form (signed).<\/u> To be completed only for internal and\/or university studies.<\/a><\/p><p>3. <a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2019\/04\/REQ-PI-PROTOCOLO.docx\" target=\"blank\"><u> Complete study protocol <\/u> (including version number and date). See indicative index in the clinical research protocol.<\/a><\/p><p>3. 1 Protocol summary.<\/p><p>4. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/4-MODELO-DE-HIP-CI-PROYECTOS-todos.docx\" target=\"_blank\" rel=\"noopener\"><u> Patient information sheet and informed consent in writing,<\/u>orally before witnesses and legal representative (version number and date), or request for exemption. CEIm-FIVO form available.<\/a><\/p><p>5. <u>Case Report Form (CRF).<\/u><\/p><p>6. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/6-MEMORIA-ECONOMICA-GENERAL-proyectos-todos.doc\" target=\"_blank\" rel=\"noopener\"><u> General economic report.<\/u><\/a><\/p><p>7. <u> BIOBANK sample availability report <\/u> (only if samples from the biobank are required).<\/p><p>8. <u> Certificate of Civil Liability Insurance <\/u> (Art 18 of Law 14\/2007) (if applicable).<\/p><p>9. <u> Responsibility delegation agreement in the case of CROs<\/u> (if applicable)<\/p><p><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/10-Solicitud-Factura-o-Exencion-tasas-CEIm-FIVO-todos.doc\" target=\"_blank\" rel=\"noopener\">10. <u> Proof of payment <\/u> (if applicable). Invoice request \/ Application for evaluation fee waiver.<\/a><\/p><p><strong> LOCAL DOCUMENTATION <\/strong> (send an original according to the CEIm-FIVO&#8217;s own template):<\/p><p>1. <u><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/REQ-PI-COMPROMISO.doc\" target=\"_blank\" rel=\"noopener\"> Commitment of the Researcher and authorisation of the Head of Service <\/a>.<\/u><\/p><p>2. <u> CV of the research team<\/u> (abbreviated format recommended).<\/p><p>3. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/REQ-PI-CONFORMIDAD.doc\" target=\"_blank\" rel=\"noopener\"><u> Agreement of involved services.<\/u> Extraordinary tests and\/or collaboration with other services<\/a> (only when applicable)<\/p><p>4. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/15-INFORME-INVESTIGADOR-PRINCIPAL.docx\" target=\"_blank\" rel=\"noopener\"><u> Principal Investigator&#8217;s Report.<\/u><\/a><\/p><p>5. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/REQ-PI-CUESTIONARIO-MEMORIA.docx\" target=\"_blank\" rel=\"noopener\"><u> Questionnaire for studies with \u20ac0 economic report.<\/u> <\/a> Only in the case of university studies.<\/p><p>6. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/REQ-PI-COMPROMISO.doc\" target=\"_blank\" rel=\"noopener\"><u> Confidentiality agreement for trainees.<\/u><\/a> Only in the case of university studies.<\/p><p><b> Submission period:<\/b> From the 1st to the 10th of each month. Documentation may be corrected until the 15th.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"ceim-meeting-calendar\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"5\" aria-controls=\"elementor-tab-content-1365\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">CEIm meeting calendar<\/span><\/div><div id=\"elementor-tab-content-1365\" class=\"eael-accordion-content clearfix\" data-tab=\"5\" aria-labelledby=\"ceim-meeting-calendar\"><p><img decoding=\"async\" class=\"alignnone wp-image-28371 size-full\" src=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2023\/04\/calendario-reunion-CEIm.png\" alt=\"\" width=\"1887\" height=\"660\" \/><\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"ceim-evaluation-fees\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"6\" aria-controls=\"elementor-tab-content-1366\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">CEIm evaluation fees<\/span><\/div><div id=\"elementor-tab-content-1366\" class=\"eael-accordion-content clearfix\" data-tab=\"6\" aria-labelledby=\"ceim-evaluation-fees\"><p><img decoding=\"async\" class=\"alignnone wp-image-28371 size-full\" src=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/tarifas-ceim.jpg\" alt=\"\" width=\"1887\" height=\"660\" srcset=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/tarifas-ceim.jpg 1887w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/tarifas-ceim-300x105.jpg 300w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/tarifas-ceim-1024x358.jpg 1024w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/tarifas-ceim-768x269.jpg 768w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/tarifas-ceim-1536x537.jpg 1536w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/tarifas-ceim-1200x420.jpg 1200w\" sizes=\"(max-width: 1887px) 100vw, 1887px\" \/><\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"contact-ceim\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"7\" aria-controls=\"elementor-tab-content-1367\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">Contact CEIm<\/span><\/div><div id=\"elementor-tab-content-1367\" class=\"eael-accordion-content clearfix\" data-tab=\"7\" aria-labelledby=\"contact-ceim\"><p><strong>CEIm Technical Secretariat<\/strong><\/p><p>Bernat Navarro, Beatriz Llatas and Carmen Taltavull<br \/>E-mail: ceim@fivo.org<\/p><p>Telephone:\u00a0(+34) 960 694 674 | (+34) 961 104 673 | (+34) 961 114 095<\/p><p>Address: Gregorio Gea, 31 CP 46009 \u2013 VALENCIA<\/p><p>Edificio D, 1\u00aa Planta Secretar\u00eda T\u00e9cnica CEIm<\/p><\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-c3ad74c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c3ad74c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-072a82d\" data-id=\"072a82d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-18305e6 elementor-widget elementor-widget-heading\" data-id=\"18305e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Management of Clinical Trial contracts<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c1ee33 elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"5c1ee33\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-5c1ee33\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"5c1ee33\" data-accordion-type=\"accordion\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"fivo-facility-suitability-management-documentation-requirements-model\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-9651\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">FIVO Facility Suitability Management (Documentation Requirements \/ Model)<\/span><\/div><div id=\"elementor-tab-content-9651\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"fivo-facility-suitability-management-documentation-requirements-model\"><p>At the <strong>IVO Foundation<\/strong>, the Medical Director is the person authorised to sign the document of facilities&#8217; suitability.<\/p><p>To make a request to process the signing of this document, the sponsor\/CRO can send an email to:\u00a0<u><a href=\"mailto:contratosestudios@fivo.org\">contratosestudios@fivo.org<\/a><\/u><\/u><\/p><p><strong>The following documentation and information must be attached to the request <\/strong>(<a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/REQUISITOS-DOCUMENTACION-GESTION-IDONEIDAD-INSTALACIONES. pdf\" target=\"_blank\" rel=\"noopener\">DOWNLOAD REQUIREMENTS FOR FACILITY SUITABILITY MANAGEMENT IN PDF FORMAT<\/a>):<\/p><ul><li>Protocol in Spanish or, failing that, the protocol in English plus a synopsis in Spanish.<\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/GESTION-IDONEIDAD-INSTALACIONES. docx\" target=\"_blank\" rel=\"noopener\"><u>Facility suitability model<\/u> completed with the data of the study indicating the services involved that will participate in the study.<\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/6-MEMORIA-ECONOMICA-GENERAL-EOm-todos. docx\" target=\"_blank\" rel=\"noopener\">General Economic Report<\/a><\/li><\/ul><p> <\/p><p><strong>In addition, the following data must be indicated in the application e-mail:<\/strong><\/p><ul><li>Name of the principal investigator<\/li><li>Service of the Hospital where the study will be carried out<\/li><li>Whether they need the document with an original signature or if a PDF scan is sufficient.<\/li><\/ul><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"clinical-trial-contract-management-documentation-requirements-internal-forms\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-9652\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">Clinical Trial Contract Management (Documentation Requirements \/ Internal Forms)<\/span><\/div><div id=\"elementor-tab-content-9652\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"clinical-trial-contract-management-documentation-requirements-internal-forms\"><p>Clinical trial contracts signed with the Instituto Valenciano de Oncolog\u00eda Foundation shall be managed in accordance with the instructions described below.<\/p><p>The contact e-mail address for contract negotiations is contratosestudios@fivo.org<\/p><p><strong>Documentation and information to be provided by the sponsor to complete the centre&#8217;s internal file<\/strong> <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/REQUISITOS-GESTION-CONTRATOS-EECC.pdf\" target=\"_blank\" rel=\"noopener\">(DOWNLOAD REQUIREMENTS FOR CLINICAL TRIAL CONTRACT MANAGEMENT [PDF].)<\/a>:<\/p><p>1. <strong>Protocol<\/strong> in English or Spanish<\/p><p>2. <strong>Summary<\/strong> of the protocol in <strong>Spanish<\/strong>.<\/p><p>3. <strong>Patient information sheet and informed consent.<\/strong><\/p><p>4. <strong>Annex 1A<\/strong> (if available at the time of signing)<\/p><p>5. <strong>Certificate of Insurance Policy<\/strong>. The following information must be included:<\/p><p><strong>Centre<\/strong>: Fundaci\u00f3n Instituto Valenciano de Oncolog\u00eda<\/p><p><strong>Address of the Centre<\/strong>: C\/ Profesor Beltr\u00e1n B\u00e1guena, 8, 46009 Valencia<\/p><p><strong>Foundation<\/strong>: Fundaci\u00f3n de Investigaci\u00f3n Cl\u00ednica del Instituto Valenciano de Oncolog\u00eda (FINCIVO)<\/p><p><strong>Foundation&#8217;s Address<\/strong>: C\/ Ricardo Mic\u00f3, n\u00ba 3 &#8211; Local n\u00ba 1 46009 Valencia<\/p><p><strong>Principal Investigator<\/strong>.<\/p><p>6. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/MEMORIA-ECONOMICA-GENERAL-1-1.odt\" target=\"_blank\" rel=\"noopener\"><strong> General economic report <\/strong><\/a>.<\/p><p>7. <strong> Powers\/delegation (Contract Research Organization, CRO)<\/strong>. Justification of the representation of the signatory parties to the contract.<\/p><p>8. <strong> Opinion of the CEIm<\/strong> (if available at the time of signing)<\/p><p>9. <strong>AEMPS auhorisation<\/strong> (if available at the time of signing)<\/p><p>10. <strong>Principal Investigator\u2019s CV<\/strong><\/p><p>11. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/11-SUMINISTRO-MEDICACION-Y-FUNGIBLE-EECC.doc\" target=\"_blank\" rel=\"noopener\"><strong> Information on the supply of experimental medication and comparative medication <\/strong> (list of medication provided and not provided). Please complete the attached form.<\/a><\/p><p>12. <a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/ESTADO-DE-LA-SOLICITUD-CEIm-AEMPS.doc\" target=\"_blank\" rel=\"noopener\"><strong> Name of the CEIm and status of the application to CEIm and AEMPS <\/strong>. Please complete the attached form<\/a>.<\/p><p> <\/p><p><strong> LOCAL ECONOMIC REPORT <\/strong><\/p><p> Concurrently, the annex to the local economic report is to be negotiated with Bernat Navarro <a href=\"mailto:bnavarro@fivo.org\">bnavarro@fivo.org<\/a> (PHONE +34 960 694 674). Depending on how the contract will be signed, one of the following forms should be used:<\/p><p>\u2013 Annexed Form on the Internal Economic Report FIVO contract (in Spanish).<br \/>\u2013 Annexed Form on the Internal Economic Report FIVO contract (bilingual). <\/p><p> <\/p><p><u>THESE ARE TWO INDEPENDENTLY MANAGED PROCESSES<\/u><\/p><p>\u2013 The body of the contract is negotiated via <a href=\"mailto:contratosestudios@fivo.org\">contratosestudios@fivo.org<\/a> (Do not copy this address in the e-mails addressed to the negotiation of the local economic report)<br \/>\u2013  The local economic report is negotiated directly with <a href=\"mailto:bnavarro@fivo.org\">bnavarro@fivo.org<\/a> (Do not copy this address in the e-mails addressed to the negotiation of the body of the contract). Once the local economic report annex is closed, it can be included in the contract.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pas-contract-management-and-research-projects-documentation-requirements-internal-forms\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"3\" aria-controls=\"elementor-tab-content-9653\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">PAS Contract Management and Research Projects (Documentation Requirements \/ Internal Forms)<\/span><\/div><div id=\"elementor-tab-content-9653\" class=\"eael-accordion-content clearfix\" data-tab=\"3\" aria-labelledby=\"pas-contract-management-and-research-projects-documentation-requirements-internal-forms\"><p><a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/06\/REQUISITOS-GESTION-CONTRATOS-EOm.pdf\" target=\"_blank\" rel=\"noopener\">REQUISITOS GESTION CONTRATOS EOm<\/a><\/p><p><a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/06\/REQUISITOS-GESTION-ADENDAS-para-EECC_EOm_PROYECTOS.pdf\" target=\"_blank\" rel=\"noopener\">REQUISITOS GESTION ADENDAS para EECC_EOm_PROYECTOS<\/a><\/p><p><a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/12-AUTORIZACION-JS-IMPLICADO-EOm-todos.doc\" target=\"_blank\" rel=\"noopener\">12- AUTORIZACION JS IMPLICADO EOm todos<\/a><\/p><p><a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/11-COMPROMISO-IP-Y-AUTORIZACION-JS-EOm-todos.doc\" target=\"_blank\" rel=\"noopener\">11- COMPROMISO IP Y AUTORIZACION JS EOm todos<\/a><\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"gestin-contratos-proyectos-de-investigacin-requisitos-documentacin-modelos-internos\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"4\" aria-controls=\"elementor-tab-content-9654\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">Gesti\u00f3n contratos Proyectos de Investigaci\u00f3n (Requisitos documentaci\u00f3n \/ Modelos Internos)<\/span><\/div><div id=\"elementor-tab-content-9654\" class=\"eael-accordion-content clearfix\" data-tab=\"4\" aria-labelledby=\"gestin-contratos-proyectos-de-investigacin-requisitos-documentacin-modelos-internos\"><p><a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/06\/REQUISITOS-GESTION-CONTRATOS-EECC.pdf\" target=\"_blank\" rel=\"noopener\">REQUISITOS GESTION CONTRATOS EECC<\/a><\/p><p><a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/06\/REQUISITOS-GESTION-CONTRATOS-PROYECTOS.pdf\" target=\"_blank\" rel=\"noopener\">REQUISITOS GESTION CONTRATOS PROYECTOS<\/a><\/p><p><a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/12-AUTORIZACION-JS-IMPLICADO-EOm-todos.doc\" target=\"_blank\" rel=\"noopener\">12- AUTORIZACION JS IMPLICADO EOm todos<\/a><\/p><p><a href=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/11-COMPROMISO-IP-Y-AUTORIZACION-JS-EOm-todos.doc\" target=\"_blank\" rel=\"noopener\">11- COMPROMISO IP Y AUTORIZACION JS EOm todos<\/a><\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"fivo-forms-for-clinical-trial-contracts\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"5\" aria-controls=\"elementor-tab-content-9655\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">FIVO Forms for Clinical Trial Contracts<\/span><\/div><div id=\"elementor-tab-content-9655\" class=\"eael-accordion-content clearfix\" data-tab=\"5\" aria-labelledby=\"fivo-forms-for-clinical-trial-contracts\"><p>Following the publication of Decree 73\/2009, of 5 June, of the Consell, which regulates the management of clinical trials and observational post-authorisation studies with medicine and medical devices. [2009\/6667], the following contract templates will be used:<\/p><ul><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/MODELO-CONTRATO-EC-FIVO-CASTELLANO-ASESORI\u0301A-JURI\u0301DICA-DEFINITIVO_2020.docx\" target=\"_blank\" rel=\"noopener\">FIVO SAMPLE CLINICAL TRIAL CONTRACT (in Spanish)<\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/MODELO-CONTRATO-EC-FIVO-BILINGUE-ASESORI\u0301A-JURI\u0301DICA-DEFINITIVO.docx\" target=\"_blank\" rel=\"noopener\">FIVO SAMPLE CLINICAL TRIAL CONTRACT (bilingual)<\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/XX-MODELO-CONTRATO-EOm-EPA-FIVO-CASTELLANO-ASESORIA-JURIDICA-DEFINITIVO.docx\" target=\"_blank\" rel=\"noopener\">FIVO SAMPLE PAS CONTRACT (in Spanish)<\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/MODELO-CONTRATO-PROYECTOS-FIVO-CASTELLANO-A_JURIDICA-LBL_2021-05-28.docx\" target=\"_blank\" rel=\"noopener\">FIVO SAMPLE PROJECT CONTRACT (in Spanish)<\/a><\/li><\/ul><p> <\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"fivo-forms-of-addenda-to-clinical-trials\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"6\" aria-controls=\"elementor-tab-content-9656\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">FIVO Forms of Addenda to Clinical Trials<\/span><\/div><div id=\"elementor-tab-content-9656\" class=\"eael-accordion-content clearfix\" data-tab=\"6\" aria-labelledby=\"fivo-forms-of-addenda-to-clinical-trials\"><p>In the event that a clinical trial is extended, the Principal Investigator is replaced, or there is a major modification that entails an increase or decrease in the initially planned cost of the clinical trial, an addendum to the contract shall be made.<\/p><p>The following addenda templates will be used:<\/p><ul><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/ADENDA-CONTRATO-EC-A_JURIDICA-LBL_2021-01-21.docx\" target=\"_blank\" rel=\"noopener\">FIVO ADDENDUM TO CLINICAL STUDY TEMPLATE (in Spanish)<\/a><\/li><li><a href=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/ADENDA-CONTRATO-EOm-EPA-A_JURIDICA-LBL_2021-02-11.docx\" target=\"_blank\" rel=\"noopener\">FIVO ADDENDUM TO PAS TEMPLATE (in Spanish)<\/a><\/li><\/ul><p>*In the event that it is necessary to sign a bilingual form of the addendum, a sworn translation must be provided, enclosing a certificate from a sworn translator accredited by the Ministry of Foreign Affairs.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"administrative-management-fees\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"7\" aria-controls=\"elementor-tab-content-9657\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">Administrative management fees<\/span><\/div><div id=\"elementor-tab-content-9657\" class=\"eael-accordion-content clearfix\" data-tab=\"7\" aria-labelledby=\"administrative-management-fees\"><p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-28392 size-full\" src=\"https:\/\/ivo22.gyoza.tech\/wp-content\/uploads\/2022\/05\/gestion-contratos-tarifas.jpg\" alt=\"\" width=\"1853\" height=\"216\" srcset=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/gestion-contratos-tarifas.jpg 1853w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/gestion-contratos-tarifas-300x35.jpg 300w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/gestion-contratos-tarifas-1024x119.jpg 1024w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/gestion-contratos-tarifas-768x90.jpg 768w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/gestion-contratos-tarifas-1536x179.jpg 1536w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/gestion-contratos-tarifas-1200x140.jpg 1200w\" sizes=\"(max-width: 1853px) 100vw, 1853px\" \/><\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"fivo-research-secretariat-contact-information\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"8\" aria-controls=\"elementor-tab-content-9658\"><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><span class=\"eael-accordion-tab-title\">FIVO Research Secretariat Contact Information<\/span><\/div><div id=\"elementor-tab-content-9658\" class=\"eael-accordion-content clearfix\" data-tab=\"8\" aria-labelledby=\"fivo-research-secretariat-contact-information\"><p><strong>FIVO Research Secretariat<\/strong><\/p><p>Bernat Navarro, Beatriz Llatas and Carmen Taltavull<br \/>E-mail: contratosestudios@fivo.org<\/p><p>Telephone:\u00a0(+34) 961 104 673 | (+34) 961 114 095<\/p><p>Address: Gregorio Gea, 31 CP 46009 \u2013 VALENCIA<\/p><p>Edificio D, 1\u00aa Planta Secretar\u00eda Investigaci\u00f3n FIVO<\/p><\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-3515611 elementor-section-height-default elementor-section-boxed elementor-section-height-default\" data-id=\"3515611\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-7becdf0\" data-id=\"7becdf0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-02c7fc9 elementor-widget elementor-widget-heading\" data-id=\"02c7fc9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Clinical trials at the IVO<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1a0584c elementor-widget elementor-widget-text-editor\" data-id=\"1a0584c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The IVO has participated in the development of most of the new cancer drugs marketed in the last 20 years and currently has one of the most clinical trials on cancer drugs in all of Spain.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4881cc3 elementor-align-center animated-slow elementor-invisible elementor-widget elementor-widget-button\" data-id=\"4881cc3\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.ivo.es\/investigacion\/ensayos-clinicos\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">see clinical trials<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-6bd4b4e\" data-id=\"6bd4b4e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9828f1d elementor-widget elementor-widget-image\" data-id=\"9828f1d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"640\" height=\"427\" src=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/LAB-AnatomiaPatologica-Microtomia-corte-de-Tejidos-en-parafina-0489.jpg\" class=\"attachment-large size-large wp-image-26585\" alt=\"\" srcset=\"https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/LAB-AnatomiaPatologica-Microtomia-corte-de-Tejidos-en-parafina-0489.jpg 1000w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/LAB-AnatomiaPatologica-Microtomia-corte-de-Tejidos-en-parafina-0489-300x200.jpg 300w, https:\/\/www.ivo.es\/wp-content\/uploads\/2022\/05\/LAB-AnatomiaPatologica-Microtomia-corte-de-Tejidos-en-parafina-0489-768x512.jpg 768w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Drug Research Ethics Committee (in Spanish, Comit\u00e9 de \u00c9tica de la Investigaci\u00f3n con medicamentos, CEIm) It is the independent body, made up of healthcare professionals and non-healthcare members, responsible for ensuring the protection of the rights, safety and well-being of subjects participating in a clinical trial and for providing public assurance in this regard. Its [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":26775,"parent":33456,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"footnotes":""},"class_list":["post-33476","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/pages\/33476","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/comments?post=33476"}],"version-history":[{"count":16,"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/pages\/33476\/revisions"}],"predecessor-version":[{"id":42231,"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/pages\/33476\/revisions\/42231"}],"up":[{"embeddable":true,"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/pages\/33456"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/media\/26775"}],"wp:attachment":[{"href":"https:\/\/www.ivo.es\/en\/wp-json\/wp\/v2\/media?parent=33476"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}